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HZNP

Horizon Therapeutics

$36.59

0.33 (0.91%)

08:35
01/13/20
01/13
08:35
01/13/20
08:35

Horizon Therapeutics announces Krystexxa, pipeline updates

Horizon Therapeutics announced that it is increasing the peak U.S. annual net sales expectations for its key growth drivers Krystexxa and teprotumumab, as well as providing several pipeline updates. Based on current strong performance, the company is increasing its peak U.S. annual net sales expectation for Krystexxa to more than $1B, from the previous expectation of more than $750M. The company continues to project Krystexxa FY19 net sales growth of more than 25%. The company also announced topline results from its MIRROR open-label pilot study, which evaluated the use of the immunomodulator methotrexate with Krystexxa to increase the response rate of Krystexxa. The results of the study demonstrated that 79%, or 11 of 14 patients, achieved a complete response, defined as the proportion of serum uric acid, or sUA, responders at Month 6. The combination was also well tolerated. Detailed results from the study will be presented at a future medical meeting. The 79% response rate is significantly higher than the 42% response rate in the Krystexxa Phase 3 clinical program, which evaluated Krystexxa alone. Krystexxa has demonstrated rapid reduction in sUA levels for people with uncontrolled gout; however, treatment with biologic medicines can, in some patients, trigger the body's immune system to develop anti-drug antibodies. These anti-drug antibodies can reduce the effectiveness of the biologic therapy. Immunomodulators such as methotrexate, which is commonly used by rheumatologists, can help reduce this reaction. The MIRROR open-label pilot study follows other studies that showed an improved response rate when Krystexxa is co-administered with methotrexate. There is a growing body of data supporting the potential of Krystexxa plus immunomodulation to become the standard therapy opposed to Krystexxa therapy alone. The company is currently conducting a separate, placebo-controlled MIRROR trial evaluating the use of Krystexxa and methotrexate. The trial, with 135 randomized patients, is designed to enable the potential for submission of results to the FDA for update to the label. In addition, the company is planning to evaluate the impact of administering Krystexxa over a significantly shorter infusion duration. The initial proof-of-concept work will begin mid-2020. Currently, Krystexxa is infused over a two-hour or longer timeframe. A shorter infusion duration could meaningfully improve the experience and convenience for patients, physicians and sites of care. Additionally, the company is evaluating additional indications for teprotumumab and is initiating an exploratory study in diffuse cutaneous scleroderma, a rare fibrotic disease with no treatment options. Diffuse cutaneous scleroderma is a subtype of scleroderma in which excess collagen production causes skin thickening and hardening, or fibrosis, over large areas of the body, usually the fingers, hands, arms, anterior trunk, legs and face. There can be significant associated organ damage, including to the gastrointestinal tract, kidneys, lungs and heart. Literature suggests that the mechanism of action of teprotumumab, which is to block the IGF-1 receptor, could have an impact on fibrotic processes, such as those that are relevant to diffuse cutaneous scleroderma. The company expects to conduct an exploratory trial beginning in the first half of 2020 to evaluate objective biomarker and clinical endpoints to inform potential subsequent larger and longer duration clinical trials.

  • 13

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  • 08

    Mar

HZNP Horizon Therapeutics
$36.59

0.33 (0.91%)

12/24/19
PIPR
12/24/19
NO CHANGE
Target $49
PIPR
Overweight
Horizon Therapeutics price target raised to $49 from $36 at Piper Jaffray
Piper Jaffray analyst David Amsellem raised his price target for Horizon Therapeutics to $49 from $36 and reiterates an Overweight rating on the shares. The stock closed MOnday at $36.28. With Horizon "on the cusp of a seminal milestone" with the eventual approval of teprotumumab for thyroid eye disease, which offers a "relatively high probability of wide adoption," that there is "ample room for significant further value creation," Amsellem tells investors in a research note. The analyst says he's received favorable feedback on teprotumumab from past key opinion leader checks and a recent physician survey. He believes Horizon shares are well positioned for multiple expansion.
01/08/20
GSCO
01/08/20
INITIATION
Target $35
GSCO
Neutral
Horizon Therapeutics initiated with a Neutral at Goldman Sachs
Goldman Sachs analyst Graig Suvannavejh initiated coverage of Horizon Therapeutics with a Neutral rating and $35 price target. The analyst views the shares as "richly valued" and sees no obvious potential stock-moving 2020 catalysts.
01/08/20
GUGG
01/08/20
NO CHANGE
Target $40
GUGG
Buy
Horizon Therapeutics named Guggenheim's best Emerging Pharma idea for 2020
Guggenheim analyst Dana Flanders believes selectivity "remains critical" in the Emerging Pharma space and sees therapeutics as best positioned into 2020 despite a strong year-end rally from generics. The analyst is bullish into Horizon Therapeutics' (HZNP) potential Q1 launch of teprotumumab and sees a "strong case" for continued multiple expansion at Bausch Health (BHC). Flanders also likes the risk/reward profiles for Emergent BioSolutions (EBS) and Bellus Health (BLU) ahead of legal and clinical catalysts. Across generics, Amneal Pharmaceuticals (AMRX) is the analyst's least preferred name due to valuation and skepticism on sustaining the company's medium-term growth above peers. Flanders calls Horizon his best idea and upped the stock's price target to $40 from $36. He also raised Bausch's target to $36 from $30 and Sell-rated Amneal's target to $3 from $2.
01/10/20
STFL
01/10/20
NO CHANGE
STFL
Buy
Cara Therapeutics named a BioPharma top pick for 2020 at Stifel
Stifel analyst Annabel Samimy maintain Horizon Therapeutics (HZNP) as a Select List and Top Pick, citing the visible growth drivers of Krystexxa and teprotumumab as well as the company's "proven execution prowess." She also called Evolus (EOLS) an "underappreciated Select List Pick" given its "excellent execution" in the cash pay neurotoxin market. Among development-stage companies, Samimy selected Cara Therapeutics (CARA) as her Top Pick, noting that it will have three clinical trial read-outs in distinct pruritus indications this year and has lost nearly all value related to Oral Korsuva despite the drug's established clinical activity. She has Buy rating and $45 price target on Horizon, Buy rating and $33 price target on Evolus and Buy rating and $33 price target on Cara shares.

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AXTA

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